🇺🇸
United States · US · US:67457-217_868dd5b8-2e28-475c-b6c3-bfc0a33fb793
Methadone Hydrochloride
Orange BookUNIISPLATC N02AC52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeN02AC52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167457217201 VIAL, MULTI-DOSE in 1 CARTON (67457-217-20) / 20 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
N021624
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "229809935B",
"rxcui": "218337",
"inchikey": "FJQXCDYVZAHXNS-UHFFFAOYSA-N",
"display_name": "METHADONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"spl_meta": {
"e72841bf-364b-49b1-8e69-7e26ddcd2657": {
"match": "brand_token",
"title": "METHADONE HYDROCHLORIDE CONCENTRATE [HIKMA PHARMACEUTICALS USA]",
"spl_version": "18",
"published_date": "2026-05-20"
}
},
"productid": "67457-217_868dd5b8-2e28-475c-b6c3-bfc0a33fb793",
"productndc": "67457-217",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "021624",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHADONE HYDROCHLORIDE",
"proprietary_name": "Methadone Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021624",
"marketing_category": "NDA",
"nonproprietary_name": "Methadone Hydrochloride",
"start_marketing_date": "20121220",
"active_numerator_strength": "10"
}Related drugs
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